Drug product
Bexarotene Capsules, 75 mg, 100 capsules per bottle, Rx Only, Manufactured for: Upsher-Smith Laboratories, LLC, Maple Grove, MN 55369. NDC: 0832-0285-00
D-1836-2019
Product summary
- Event
- Event 83501
- Status
- Terminated
- Classification
- Class II
- Quantity
- 166 bottles
- Official record key
drug-enforcement:D-1836-2019
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot: A2610. exp 3/2020
Distribution pattern: KY, OH, NJ, LA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications